Methods and apparatuses for measuring tissue stiffness changes using ultrasound elasticity imaging

1. A method of evaluating tissue stiffness of a target area, comprising:

positioning an ultrasound elasticity imaging apparatus adjacent a surface of an area of tissue where the target area is located;

applying a first amount of force to the area of the tissue to be evaluated to provide a first amount of applied strain on the target area;

increasing the force on the strained tissue until a second amount of force is applied, the second amount of force providing a second amount of applied strain on the target area;

directing a plurality of ultrasound beams at the tissue and acquiring a plurality of ultrasound echoes from the strained tissue in the target area to calculate an amount of developed strain within the target area, the amount of developed strain being calculated at a plurality of points across a strain range between the first amount of applied strain and the second amount of applied strain; and

determining a shear wave velocity at a plurality of locations in the target area and comparing the applied strain to the determined shear wave velocities to evaluate a tissue stiffness of the target area,

wherein the tissue stiffness is determined by the relationship between the determined shear wave velocities and the amount of applied strain, and the tissue stiffness is used to identify a condition of the target area being evaluated based on a numerical, nonlinear parameter that is extracted from the relationship between the developed strain and the applied strain.

2. The method of claim 1 , wherein the amount of developed strain is calculated using speckle tracking data obtained by the ultrasound elasticity imaging apparatus.

3. The method of claim 1 , wherein the developed strain is calculated continuously across a strain range between the first amount of applied strain and the second amount of applied strain.

4. The method of claim 1 , wherein the calculation of developed strain is normalized.

5. The method of claim 4 , wherein the calculation of developed strain is normalized by providing an insert between the tissue and a surface of the ultrasound elasticity imaging apparatus, the method further comprising:

calculating an amount of strain applied to the insert using speckle tracking data obtained by the ultrasound elasticity imaging apparatus.

6. The method of claim 5 , wherein the insert has a thickness that is between about 5 mm and 30 mm.

7. The method of claim 5 , wherein the insert has a thickness that is between about 10 mm and 16 mm.

8. The method of claim 5 , wherein the insert is generally ultrasonically transparent.

9. The method of claim 5 , wherein the insert has a predetermined Young's modulus.

10. The method of claim 5 , wherein the insert is flexible to deform when coupled to the ultrasound transducer and the insert is brought into contact with soft tissue of a patient.

11. The method of claim 5 , wherein the insert is configured to experience an applied strain of at least 20% without breaking.

12. The method of claim 5 , wherein the insert is configured to experience an applied strain of at least 30% without breaking.

13. The method of claim 1 , wherein the relationship between the amount of developed strain and the amount of applied strain is used to identify the condition of the target area being evaluated.

14. The method of claim 13 , wherein the condition relates to inflammation, edema development, fibrosis development, or a mix thereof.

15. The method of claim 1 , wherein the condition is Crohn's disease.

16. The method of claim 1 , wherein the relationship is graphically depicted.